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U.S. Department of Health and Human Services

Final Rules: Food Additives and Color Additives

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Petition(s): FDA action

Citric Acid and Certain Citrate Derivatives; Affirmation of GRAS Status as Direct Human Food Ingredients

Docket number (legacy and/or former docket number(s)): (80N-0218)
Subject additive and intended use: affirming citric acid, dibasic ammonium citrate, calcium citrate, potassium citrate, sodium citrate, isopropyl citrate, stearyl citrate, and triethyl citrate as generally recognized as safe (GRAS) for use as direct human food ingredients
21 CFR* affected: 184.1033; Citric acid
184.1140; Ammonium citrate, dibasic
184.1195; Calcium citrate
184.1386; Isopropyl citrate
184.1625; Potassium citrate
184.1751; Sodium citrate
184.1851; Stearyl citrate
184.1911; Triethyl citrate
Substance(s)*, (CAS Registry® No.):
  • citric acid, (77-92-9)
  • ammonium citrate, dibasic, (3012-65-5)
  • calcium citrate, (813-94-5)
  • isopropyl citrate, (39413-05-3)
  •  - monoisopropyl citrate, (1321-57-9)
  •  - diisopropyl citrate, (100328-53-8)
  •  - triisopropyl citrate, (74592-76-0)
  • potassium citrate, (6100-05-6)
  • sodium citrate, (68-04-2)
  • stearyl citrate, (1337-33-3)
  •  - monostearyl citrate, (1323-66-6)
  •  - distearyl citrate, (29589-99-9)
  •  - tristearyl citrate, (7775-50-0)
  • triethyl citrate, (77-93-0)
  • Federal Register publication history: Jan 7, 1983; 48 FR 834; Proposed rule
    Aug 20, 1992; 57 FR 37738; Final tentative rule
    Dec 12, 1994; 59 FR 63894; Final rule; Effective date: Dec 12, 1994


     

    *Definitions

    • 21 CFR: Title 21 of the Code of Federal Regulations.
    • Substance: The name of the substance listed in the CFR.
    • CAS Registry® No.: Chemical Abstract Service (CAS) Registry Number® for the substance.
    • Petitions (see also Questions and Answers About the Petition Process)
      • FAP: Food Additive Petition
      • CAP: Color Additive Petition
      • GRP: GRAS Affirmation Petition (replaced by GRAS Notification Program in 1998)
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